Results Announced for Investigational Hepatitis C Drug

Boehringer Ingelheim announced results from the pivotal Phase 3 STARTVerso 1 trial of faldaprevir (BI 201335) in combination with pegylated interferon and ribavirin (PegIFN/RBV). Faldaprevir (BI 201335) is an investigational, oral protease inhibitor that is designed to target viral replication in the liver.

STARTVerso1 is a double-blind, placebo-controlled trial which enrolled and treated 652 treatment-naive patients from Europe and Japan infected with chronic genotype-1 hepatitis C virus (HCV). Patients were randomized to receive PegIFN/RBV in combination with a once-daily dose of 120mg faldaprevir, 240mg faldaprevir or placebo.Treatment duration depended on whether patients met criteria for early treatment success (ETS).

Group 1 received 24 weeks of placebo with PegIFN/RBV followed by 24 weeks of PegIFN/RBV (48 weeks total treatment). Group 2 received 12 weeks of 120mg faldaprevir with PegIFN/RBV. Patients who met ETS criteria received an additional 12 weeks of PegIFN/RBV (24 weeks total treatment). Patients who did not meet ETS criteria received an additional 12 weeks of 120mg faldaprevir with PegIFN/RBV followed by 24 weeks of PegIFN/RBV (48 weeks total treatment). Group 3 received 12 weeks 240mg faldaprevir with PegIFN/RBV followed by 12 weeks of PegIFN/RBV. Patients who met ETS criteria stopped treatment after 24 weeks total treatment. Patients who did not meet ETS criteria received an additional 24 weeks of PegIFN/RBV (48 weeks total treatment).

In previously untreated patients with genotype-1 HCV who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed (SVR12) compared to 52% of patients receiving PegIFN/RBV plus placebo (P<0.0001). ETS was also achieved by 87% and 89% of patients treated with the faldaprevir-based regimen (120mg or 240mg, respectively). Of those patients who completed treatment early, 86% and 89% (120mg or 240mg, respectively) went on to achieve viral cure (SVR12). This demonstrated that an overall treatment regimen of 24 weeks was sufficient to achieve viral cure in most patients, cutting treatment duration in half when compared to treatment with PegIFN/RBV alone (48 weeks).